Little is known about how trial site costs vary around the world. In this sample, most patients (60%) and sites (57%) enrolled were outside of North America. In Africa, Central Europe, Middle East, and Latin America, the cost per site was about 50% of the cost per site in North America. (PubMed)
Gottlieb encourages drug sponsors to provide expanded access
FDA Commissioner Scott Gottlieb and his top aides are encouraging drug sponsors to continue providing a study drug that may have provided a benefit to especially needy clinical trial patients, after the study ends and before the new treatment is officially approved. (CenterWatch)
Contributed article. The importance of a holistic perspective in investigator selection
A successful business collaboration is rooted in respect, transparency, and a big picture perspective. When these characteristics accompany the creation of a partnership, they ensure the sustainability of the relationship. This philosophy is integral to investigator selection activities. As a new CRA, I was ruffled when a site I evaluated, Read more
Guest interview. Leveraging artificial intelligence to manage clinical trials
Leveraging artificial intelligence to manage clinical trials An interview with Kim Walpole, Co-Founder and CEO of Trials.ai. Conducted by Tatsiana Vertak Tatsiana: What does Trials.ai do? Kim: At Trials.ai we are on a mission to get treatments to patients faster by optimizing clinical trial protocols for speed and success. We Read more
Insider Tip: 8 Steps to Follow When Building Your Next Clinical Trial Website
1. Make the language reader-friendly. 2. Create the website for your target audience. 3. Provide relevant and informative details about the trial. And more. (Clinical Site Services)
Solving pharma’s ‘big text’ problem with NLP
There are about 27m articles in PubMed and 280,000 studies on ClinicalTrials.gov – so how does the industry begin to make sense of all this data? (outsourcing-pharma.com)
The false positive rate of published clinical research findings could be 35%
It has been suggested that medical research is facing a “replication crisis.” This article shows that, by using simple mathematics, it is possible to predict that, using a significance level of 0.05, up to 35% of published clinical research findings may be false. One solution to reducing the high false positive rate is to raise the bar of significance from 5% to 0.5%. (castor)
Focus of genomic-driven clinical trials shifts to rare cancers
There is a vibrant field of clinical research into new approaches for tackling cancer, and the picture is particularly positive for patients with rare tumor types that have received limited attention in the past. As a proportion of the patients in phase 1 studies, the common cancer types are decreasing and the uncommon types are increasing. (Medical Xpress)
Can Flatiron succeed in changing the clinical trial model?
Flatiron Health, a small tech company acquired by Roche, is trying to use real-world data from patient electronic medical records to replace more traditional clinical trial data. One of their major goals is to use data from health records to mimic a control group. However, FDA is not fully on board with the prospect of replacing control groups. (STAT)
The physician-sponsored IDE clinical trial
The Physician-Sponsored Investigational Device Exemption (PS-IDE) clinical trial is when a physician acts as a sponsor-investigator and both initiates and actually conducts, alone or with others, a drug or device study. It’s a challenge for the hospital or site to accommodate a physician who is conducting a PS-IDE trial because they have traditionally performed the site responsibilities and activities only. (ACRPnet.org)
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